Cmc Chemistry Manufacturing Control Jobs (NOW HIRING)

PATH current employees - please log in and apply Here

PATH is a global nonprofit dedicated to achieving health equity. With more than 40 years of experience forging multisector partnerships and with expertise in science, economics, technology, advocacy, and dozens of other specialties, PATH develops and scales up innovative solutions to the world's most pressing health challenges.

PATH's Center for Vaccine Innovation and Access (CVIA) brings together our expertise across every stage of the long and complex process of vaccine research, development, and delivery to make lifesaving vaccines widely available to children and communities across the world. CVIA's current portfolio encompasses more than two dozen vaccines either in development or already in use to protect against fifteen different diseases. Our focus is on vaccines to address the leading diseases that claim children's lives worldwide: pneumonia, diarrheal disease, and malaria; as well as other global health priorities, such as polio and meningitis. We work in partnership with national health ministries, pharmaceutical manufacturers, donors, international financing and regulatory organizations, and many others. PATH has led numerous global partnerships, including the award-winning Meningitis Vaccine Project and the Malaria Vaccine Initiative, which helped develop the first malaria vaccine candidate recommended for pilot implementation.

CVIA seeks a Global Head of Chemistry, Manufacturing and Controls, and Non-clinical Toxicology (Global Head of CMC) to help further our mission to ensure affordable and accessible vaccines for people living in low-income settings. The Global Head of CMC provides leadership and management, operational excellence, and technical expertise to all CMC & NT activities within the CVIA portfolio of vaccine candidates and projects through collaboration with CVIA Project Teams, CVIA Diseases and Functional Areas, and CVIA's vaccine development partners. This role is also responsible for the assessment of new partnership opportunities with respect to process development, product analytics, manufacturing, and quality control, adherence to WHO Good Manufacturing Practices (GMP) and Good Laboratory Practices (GLP) non-clinical safety assessment and toxicity studies of biological products. The CMC team is comprised of approximately 8 CMC experts and also draws on consultants for specialized competencies.

The Global Head of CMC is a member of the CVIA leadership team (CVIA LT) and is responsible for CVIA-wide business plan creation and implementation, change initiative leadership, talent management, and proactive partnership in developing comprehensive cross-disciplinary tactics and enabling exceptional execution through cross-functional collaboration.

Responsibilities:

Chemistry, Manufacturing and Controls (CMC)

• Functional area-wide leadership and management of Chemistry, Manufacturing and Control, and Non-Clinical Toxicology functional activities, CMC and nonclinical safety assessment and toxicology (NT) functional activities of project team work to ensure on-time and on-budget delivery of CMC & NT-related project objectives and milestones as well as compliance with PATH policies and procedures and international standards (e.g., WHO).
• Provide strategic and technical guidance to CMC team members on project teams on process development, product analytics, formulation and fill, final manufacturing process and facility design and needs, and quality control thereof, investigational product supply and stability, as well as in vivo and in vitro safety and toxicity testing performed before and during the clinical development to demonstrate non-clinical safety and tolerability of candidate vaccine products.
• Oversee CMC team preparation and review of reports for partners and donors including project status, risk identification, and potential mitigation strategies.
• Ensure CMC team support for regulatory submissions such as eCTD Modules 2.3 and 3, by authoring or reviewing CMC content.
• Interact with partners to provide oversight, guidance, and evaluations of processes in development, laboratories and manufacturing facilities, including process development, product analytics, formulation and fill, manufacturing, and quality control and Validation (Product, Process, Method and Packaging) thereof.
• Prepare and review quality control guidelines and validation protocols for vaccine process, formulation, product analytical assay development, and in vivo and in vitro safety, toxicity testing and packaging validation.
• Evaluate industrial processes for robustness, cost efficiency, compliance, quality control, and health/safety/environmental requirements and consider how new tools, such as AI, can be applied.
• Provide guidance for optimal process and technology transfer from R&D to commercial operations.
• Perform technical review of CMC plans and technical documentation relative to vaccine manufacturing production, facilities and product analytics, including primary accountability for technical content and quality of regulatory documents submitted by CVIA.
• Conduct technical due diligence of potential partners and vendors for process development, manufacturing, quality control, and safety and toxicity testing.
• Review plans against quality control requirements including WHO Prequalification and stringent regulatory authority standards.
• As needed, serve as CMC lead on more complex project(s) and/or lead CMC technical assistance projects
• Contribute to partner identification efforts to support product transfer to commercial manufacturers in LMICs.

Management & Leadership

• Member of the CVIA LT and successfully partnering with other CVIA leaders to support the goals and objectives of vaccine development and introduction.
• Develop strong partnership with cross-functional peers to ensure overall integrated development and introduction plans and tactics.
• Ensure resource allocation across vaccine development and introduction projects, technical assistance projects, and change initiatives by providing CMC & NT resources as needed.
• Develop and enforce functional area norms and standards to ensure quality of CMC & NT technical support on all projects supported by the group.
• Recruit, supervise, coach, and develop CMC & NT staff.

Required skills and experience:

• 15+ years of vaccine or biologics industry experience.
• Ph.D. or master's in chemistry or vaccine-related field of study.
• Experience in method, equipment and process validation, and development and validation of product analytics in a cGMP regulated environment.
• Prefer previous work experience with low-resource setting country manufacturers.
• Reputation as a flexible team player with the ability to forge consensus in a project-based matrix organization and align with other vaccine development and introduction leaders.
• Demonstrated senior management level capacity to manage diverse and varied job responsibilities.
• Excellent written (especially technical writing), verbal and interpersonal communication skills.
• Ability and willingness to travel domestically and internationally, up to 25% annually.
• Must have legal authorization to work in PATH country office location.

PATH is a diverse nonprofit organization that creates a culture of collaboration and partnership. Learn more about the impact you can make globallyhere.

We offer our employees a competitive salary and generous benefits. For candidates based in the U.S., the annual salary range for this position is $320,000-$380,000. The final salary is based on a variety of objective factors. PATH provides a comprehensive benefit package that includes 15 vacation, 11 holiday, 2 personal, and 12 sick days per year; medical and dental plans; life insurance; and disability and retirement benefits. For more details click here.
Remote & Hybrid Work
PATH operates within a hybrid workplace model unless otherwise noted. Hybrid employees reside within commuting distance of one of our PATH offices. PATH's US offices are located in Seattle, WA, and Washington, DC. This position is approved to be a remote employee from a US state where PATH is registered.